Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

San Donato Group (GSD)

Status: Enrolling

Conditions: Pregnancy Complications; Preeclampsia; Immunologic Disease; Pregnancy, High Risk; Antiphospholipid Antibody Syndrome Primary; Rheumatic Diseases

Treatments: Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

Study type: Observational

Funder types: Other

Identifiers

NCT05786235

APS_FLT1/PLGF

Details and patient eligibility

About

The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS.

To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM).

For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Group 1

  1. Pregnant patients between the ages of 18 and 45 years.
  2. Diagnosis of primary APS, according to international classification criteria.

• Group 2

  1. Pregnant patients between the ages of 18 and 45 years.
  2. Patients with at least one previous full-term pregnancy.
  3. No diagnosis of APS, according to international classification criteria.

Exclusion criteria

• Group 1

  1. PMA pregnancies.
  2. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
  3. Previous thrombotic event
  4. Chronic renal failure not related to AD
  5. Previous history of oncology

• Group 2

  1. Pregnancy by PMA.
  2. Previous history of polyabortion and/or late pregnancy complications.
  3. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
  4. Previous thrombotic event
  5. Previous history of oncology

Trial design

60 participants in 2 patient groups

pregnant patients with primary APS

Description:

Diagnosis of primary APS, according to international classification criteria

Treatment:

Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

pregnant patients who do not have APS

Description:

Patients with at least one previous full-term pregnancy No diagnosis of APS, according to international classification criteria

Treatment:

Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)